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# Panel OKs CDER Quality Management Maturity Program
- URL: https://www.fdaweb.com/panel-oks-cder-quality-management-maturity-program/
- Published: 2022-11-03T12:00:00.000Z
- Updated: 2026-09-14T18:05:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153126

FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee 11/2 voted 9 to 0 to recommend that CDER move forward with developing and implementing its long-planned Quality Management Maturity (QMM) program. “QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement,” the Center says. It has proposed using a rating system to help incentivize drug makers to adopt more mature quality management practices at their facilities that will reduce drug shortages and improve supply chain resiliency. To view a video of the committee meeting, click [here](https://youtu.be/78XsEBZuVBc?ref=fdaweb.com).

Last year, CDER director **Patrizia Cavazzoni** outlined the principles ([see story](https://www.fdaweb.com/cder-head-talks-quality-management-maturity/)) behind the Center’s push toward QMM. At the time, she said the agency needs to make sure that manufacturers have more mature quality management systems that “really proactively focus on performance and outcomes that affect the patient, rather than only being focused on ticking boxes, and process metrics…”

A [recent white paper](https://www.fda.gov/media/157432/download?ref=fdaweb.com) said that “(c)hanging the course of pharmaceutical quality by using a QMM rating system is a move toward performance-based regulation of the pharmaceutical industry.” The agency said that a root cause of many drug shortages is the absence of incentives for manufacturers to strive for more than simply meeting GMP regulations and to develop mature quality management systems.

FDA said the QMM ratings will be transparent and publicly available, and they likely will be used to “inform regulators and purchasers about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. FDA also believes drug purchasers will benefit greatly by increased quality transparency at firms which in turn will lead the drug industry striving to improve its quality rating. QMM ratings could also support increased flexibility for manufacturers to make postapproval manufacturing changes with less regulatory oversight, incentivizing continual improvement,” it said.

The white paper hinted that QMM ratings will go beyond GMP inspections to “measure how far a site’s pharmaceutical quality system (PQS) rises above the minimum requirements. Simple adherence to GMP standards does not indicate, for example, that a firm is investing in improvements to prevent supply disruptions.”

During the panel meeting, FDA officials said that ratings will reflect the QMM at a manufacturing site and not the quality of the process, and that high ratings will not be a “guarantee” for a site’s products. One of the key challenges to achieving QMM will be separating its assessments from GMP inspections. The QMM assessment is not intended to be used in lieu of or as a surrogate for establishment inspections and does not evaluate compliance with GMPs, CDER Division of Quality Intelligence director **Alex Viehmann** told the panel meeting.

The QMM program has a long way to go before being implemented, CDER officials said. The agency still needs to develop a protocol for QMM assessments, a rubric for scoring the assessments, and there are many operational considerations to be defined — and much of this work will be conducted with stakeholder input, which was also endorsed by several panel members during their vote to support the assessment program.

For the most part, industry favors FDA’s effort to provide incentives for manufacturers to strive beyond meeting GMP requirements and developing more mature quality management systems. In comments submitted in preparation for the panel meeting, Pharmaceutical Research and Manufacturers of America (PhRMA) [said](https://www.regulations.gov/comment/FDA-2022-N-1777-0006?ref=fdaweb.com) FDA needs to confirm that any QMM program it develops would be voluntary. Further, it says, under any voluntary program FDA should make clear that any QMM-related value or score would not be publicly disclosed, including rankings or comparisons among and between firms. PhRMA says manufacturers could voluntarily disclose such ratings to appropriate stakeholders such as purchasers in the normal course of business.

Additionally, the Biotechnology Innovation Organization (BIO) submitted [comments](https://www.regulations.gov/comment/FDA-2022-N-1777-0007?ref=fdaweb.com) that echoed PhRMA’s recommendation about the program being voluntary. BIO said industry would “likely have concerns about compliance issues being raised by FDA staff during QMM reviews which could lead to a lack of transparency and reluctance to participate. Alternative approaches, such as an independent third-party assessment under appropriate confidentiality agreements, would likely alleviate those concerns.”

BIO also said that FDA’s “public release of QMM ratings could result in consumer confusion and an inability to distinguish between quality system maturity and product quality. Instead, these values should be held by the independent assessor and the participating sites. The information should only be shared by the participating site to outside parties at their discretion with the ability to be verified by the independent assessors.”

And the Association for Accessible Medicine and its generic drug [members said](https://www.regulations.gov/comment/FDA-2022-N-1777-0008?ref=fdaweb.com) they are concerned whether QMM can be “accurately measured, normalized, and applied across different-sized companies, with different types of supply chains and products, in different jurisdictions, and with different corporate structures, in a meaningful and consistent manner that achieves the goals of the program.” The group said they are concerned that QMM will “add operational costs and complexity without commensurate return, thereby jeopardizing patient access to medicines by driving companies away from manufacturing certain drugs.”